Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of histamine human immunoglobulin in the treatment of chronic spontaneous urticaria (csu)

Conditions: Chronic Spontaneous Urticaria

Summary: the goal of this clinical trial is to study patients with chronic spontaneous urticaria. the main question it aims to answer is the efficacy and safety of histamine human immunoglobulin (shuyangminning) in the treatment of chronic spontaneous urticaria.


Eligibility criteria:
inclusion criteria: 1. written informed consent must be obtained before any assessment is performed； 2. age ≥ 18 years； 3. meet the diagnostic criteria of chronic spontaneous urticaria from《guideline for diagnosis and treatment of urticaria in china（2022）》and follow the doctor's advice；the patient had urticaria symptoms in the previous week before enrollment, and uas7 score(range 0-42) ≥ 7; 4. patients with uncontrolled urticaria are regularly treated with standard single-dose antihistamines regularly for 2 weeks before screening; exclusion criteria: 1. pregnant or nursing (lactating) women; 2. patients with malignant tumors, severe liver and kidney diseases, hematological disorders, autoimmune diseases(such as systemic lupus erythematosus, sjogren's syndrome, dermatomyositis, myositis, systemic vasculitis, systemic sclerosis, rheumatoid arthritis, spondyloarthropathy or other rheumatic immune diseases evaluated by the physician that are not suitable for inclusion), chronic serious infections, diabetic peripheral neuropathy, psychosis, and other diseases or medical histories that may affect normal efficacy evaluation and/or subject safety evaluation； 3. history of drug or alcohol abuse; 4. patients who discontinue systemic use of glucocorticoids and other immunosuppressants(such as cyclosporin a, wilfordii , etc.) that affect immune function for less than 4 weeks;patients who discontinue systemic use of biologics (e.g., omalizumab) for less than 3 months; 5. patients with symptoms of urticaria and/or angioedema, including but not limited to urticaria vasculitis, serum sickness like reaction, bullous pemphigoid, mastocytosis, neutrophilic urticaria dermatosis, schnitzler syndrome, autoinflammatory response syndromes (e.g., tumor necrosis factor receptor-associated periodic fever syndrome, familial mediterranean fever, mevaldate kinase deficiency, etc.);or other chronic itchy skin conditions, such as atopic dermatitis, dermatitis herpetiformis, and pruritus senile; 6. allergic to human immunoglobulin; 7. history of other severe allergic reactions; 8. patients with pathological arrhythmias and a history of organic heart disease; patients with known or suspected qt prolongation; or patients who are unable to discontinue medications that cause qt prolongation during the trial； 9. subjects whom the investigator considers unsuitable for other reasons.
post-line treatment with teniposide for c-myc-driven extensive-stage small cell lung cancer

Conditions: Extensive-stage Small Cell Lung Cancer (ES-SCLC); Thoracic Neoplasms; Lung Neoplasms; Lung Diseases

Summary: the study is being conducted to investigate the efficacy and safety of teniposide in patients with extensive-stage small cell lung cancer who have failed standard treatment and with high expression of the c-myc-driven fbxw2/myc gene. based on the results, the study will explore the correlation between the expression of fbxw2/myc and the efficacy of teniposide.


Eligibility criteria:
inclusion criteria: 1. extensive stage small cell lung cancer 2. progression after receiving at least one chemotherapy drug treatment in the past; 3. ecog score 0-1 4. c-myc-driven 5. expected survival period ≥3 months 6. age: 18-75 years old; 7. the informed consent form complies with the ich-gcp principles. exclusion criteria: 1. no measurable lesions 2. other severe and persistent diseases or organ system dysfunction; 3. women planning pregnancy or men planning family planning; 4. women who are pregnant or breastfeeding; 5. those who cannot follow the research protocol provided by the investigator.

Keywords: c-myc sclc phase ii post-line
clinical evaluation of color stability of direct composite resin veneers in vital anterior teeth

Conditions: Tooth Discoloration

Summary: assess color stability of direct veneers over an 18-month recall periods

in today's restorative dentistry, aesthetics has become essential. the primary determinants of the aesthetics of natural teeth are color and form. the significance of color in dental science has greatly increased during the past few decades. techniques to restore teeth to their natural appearance have been developed in direct response to patient demand for cosmetic dental procedures. in contemporary cosmetic dentistry, discolorations are often seen as an aesthetic concern. in order to correct cosmetic flaws in color and form, direct laminate veneers entail the creative application of resin composite material to the tooth surfaces. because they may be completed chairside, are readily repaired, and have abrasion rates that are similar to those of real teeth, they are viewed as competitors to ceramic veneers. with direct resin composite veneers, color stability is thought to be a common clinical issue that reduces the aesthetic result over an extended period of clinical service. the capacity of any dental material to retain its original color is known as color stability. the clinical restoration process is streamlined with the introduction of universal composites, which also considerably reduce chair-side time and simplify the color matching such as omnichroma.

Eligibility criteria:
inclusion criteria: * have good hygiene. * no medical diseases * discolored vital anterior teeth exclusion criteria: * para functional activities. * non vital teeth. * severe intrinsic discoloration.
using mass spectrometry (easym) detecting minimal residual disease (mrd) in multiple myeloma

Conditions: Multiple Myeloma

Summary: the presence of minimal residual disease (mrd) is an important prognostic factor for multiple myeloma, while m-protein is a widely accepted biomarker used for multiple myeloma (mm) diagnose. detecting mrd by monitoring m-protein using mass spectrometry (ms) is promising due to its high analytical sensitivity. to evaluate the correlation between ms-mrd and overall disease burden, over 60 patients with 500+ samples were identified for this study. the m-protein sequence and the patient-specific m-protein peptides of each patient were obtained by de novo protein sequencing platform using the diagnostic serum (\> 30g/l). the follow- up samples were then measured by a parallel reaction monitoring (prm) assay.


Eligibility criteria:
inclusion criteria: subjects with available baseline and sequential serum samples. exclusion criteria: subjects without baseline and sequential serum samples.

Keywords: mass spectrometry serum immunoglobulin minimal residual disease mrd easym m protein
trental & vitamin e for radiation-induced fibrosis

Conditions: Fibrosis

Summary: this study seeks to determine if a combination of trental and vitamin e prevents the development of radiation fibrosis in women treated with radiation for the definitive management of their breast cancer.

radiation fibrosis occurs in approximately 25% of those women treated with radiation for breast cancer. of these, approximately 3 to 5% will develop into an acute, painful form of fibrosis. mild fibrosis can present as a thicker or more dense breast where the acute form can cause pain in the breast, significant hardening, and inflammation. treatments for fibrosis are lacking, with the primary treatment being hyperbaric oxygen therapy. the combination of trental \& vitamin e has been used with success in europe and at the university of iowa. the focus of this study is to prevent fibrosis through intervention with trental \& vitamin e. the study has two arms, a control arm and an intervention arm. the study is not blinded. measurements are taken at standard follow-up visits to measure breast density and lymphedema.

Eligibility criteria:
inclusion criteria: * patients with histologically documented cancer of the breast or dcis or head and neck referred for definitive radiation with curative intent. * no evidence of metastatic disease. * minimum life expectancy of at least 12 months. * aged greater than 20 years. * if female, pregnancy excluded. * no documented history of collagen vascular disease. exclusion criteria: * cognitively impaired patients * prisoners * no histology available * documented metastatic disease * allergy to trental * life expectance of less than 12 months. * aged less than 20 years * collagen vascular disease present * pregnant * history of liver disease * use of anticoagulants

Keywords: breast neoplasms radiotherapy
treatment of sequelae caused by severe brain injury with autologous adipose-derived mesenchymal stem cells

Conditions: The Sequelae Caused by Severe Brain Injury

Summary: the study is to investigate the efficacy and safety of autologous transplantation of adipose-derived mesenchymal stem cells in patients with the sequelae caused by severe brain injury.


Eligibility criteria:
inclusion criteria: * subject has a confirmed diagnosis of a brain avm (arteriovenous malformation). * stroke-like symptoms, including paralysis, caused by brain avm hemorrhage. * subject's modified rankin scale (mrs) grades iv\~v. * ages between 20\~40 years. * estimated life expectancy must be greater than 2 months. * signed informed consent from the subject. exclusion criteria: * pregnancy test positive. * subject infected with hepatitis c, hiv or syphilis. * subject not suitable for liposuction surgery. * subject not eligible for pet or mri. * subject enrolled in any other cell therapy studies within the past 30 days. * subject deemed to be not suitable for the study by the investigator.
multi-centre trial comparing three artemisinin-based combination treatments on p. falciparum malaria

Conditions: Plasmodium Falciparum Malaria

Summary: the purpose of this open randomised multi-centre clinical trial is to test the hypothesis that three pills of the fixed dose combination artesunate/sulfamethoxypyrazine/pyrimethamine, administered over 24 hours is not inferior in efficacy to the same drug administered over 48 hours and that the fixed dose combination artesunate/sulfamethoxypyrazine/pyrimethamine as/smp fdc, independently of the duration of its dose interval, is not inferior in efficacy to 6 - 24 pills (number of pills administered to respectively children and adults)of the 60 hours treatment of artemether/lumefantrine for the treatment of uncomplicated p. falciparum malaria.


Eligibility criteria:
inclusion criteria: * age at least 6 months, * weight at least 5 kg, * residing in one of the four countries (mali, cameroon, sudan, rwanda), * able to receive oral treatment, * having an axillary body temperature of more than 37,5 degrees celsius or history of fever within the proceeding 24 hours, * suffering from a mono specific p. falciparum infection with a parasite density between 2000 and 200000 asexual forms per micro litre of blood. exclusion criteria: * presence of severe or complicated malaria (who 2000), * severe concomitant pathology or one that needs a medical follow-up incompatible with the study, * allergic to one of the drugs involved in this study, * pregnant (reported pregnancy, detected clinically or with the β hcg test), * use of one of the anti-malaria drugs involved in this study during 28 days preceding inclusion.

Keywords: open randomized multi-centre clinical trial in africa uncomplicated p. falciparum malaria artemisinin-based combination therapy artesunate + sulfalene + pyrimethamine 24 hour treatment artemether + lumefantrine
study of pulmonary complications in pediatric patients with storage disorders undergoing allogeneic hematopoietic stem cell transplantation

Conditions: I Cell Disease; Fucosidosis; Globoid Cell Leukodystrophy; Adrenoleukodystrophy; Mannosidosis; Niemann-Pick Disease; Pulmonary Complications; Mucopolysaccharidosis I; Mucopolysaccharidosis VI; Metachromatic Leukodystrophy; Gaucher's Disease; Wolman Disease

Summary: objectives: i. evaluate bronchoalveolar lavage fluid and serum obtained from pediatric patients with storage disorders prior to allogeneic hematopoietic stem cell transplantation (hsct) for the presence of proinflammatory cytokines and for the production of nitric oxide by alveolar macrophages to identify possible risk factors for pulmonary complications. ii. investigate the underlying mechanism for the development of significant pulmonary complications in these patients during hsct. iii. evaluate bronchoalveolar lavage fluid and serum obtained from these same patients at the time a pulmonary complication develops post-hsct, or at 60 days post-hsct if there has been no pulmonary complications.

protocol outline: patients undergo bronchoscopy with bronchoalveolar lavage (bal) prior to allogeneic hematopoietic stem cell transplantation (hsct). elisa assays for cytokines are performed. patients are followed post-hsct for the development of transplant related pulmonary complications. a repeat bronchoscopy with bal is performed at the time pulmonary complications develop or at day 60 post-hsct if no complications develop. cytokine assays are repeated.

Eligibility criteria:
* diagnosis of an inborn error of metabolism eligible for allogeneic hematopoietic stem cell transplantation on protocol umn-mt-1995-01

Keywords: gaucher's disease i cell disease niemann-pick disease wolman disease adrenoleukodystrophy disease-related problem/condition fucosidosis genetic diseases and dysmorphic syndromes globoid cell leukodystrophy inborn errors of metabolism mannosidosis metachromatic leukodystrophy mucopolysaccharidosis mucopolysaccharidosis i mucopolysaccharidosis vi oncologic disorders pulmonary complications rare disease sphingolipidoses
effect of one year elexacaftor-tezacaftor-ivacaftor treatment

Conditions: Cystic Fibrosis

Summary: the development of cftr (cystic fibrosis conductance transmembrane regulator) modulators for people with cystic fibrosis (pwcf) and eligible for these treatments is a true therapeutic revolution. the major beneficial effect of cftr modulators (cftrm) on pulmonary function and the reduction of pulmonary exacerbations should have a considerable impact on the quality of life and patient's life expectancy. data on the impact of cftrm on glucose tolerance abnormalities are still very fragmentary. the investigators can think that their use, earlier and earlier in the history of the disease, will transform the evolutionary trajectories of patients on the respiratory, nutritional and metabolic levels. diabetes represents a major challenge in the management of pwcf because it is a factor in morbidity and mortality at all stages of the disease, from children to patients with terminal respiratory failure requiring lung transplantation. early abnormalities in glucose tolerance observed in childhood, before the stage of diabetes, are also associated with poor pulmonary and nutritional outcomes. experimental data suggest a positive effect of cftrm on insulin secretion. however, investigators do not currently know the impact of cftrm in patients with very early glucose disorders or at the stage of diabetes treated with insulin. recently continuous glucose measurement (cgm) devices represent very effective tools for assessing abnormalities in glucose tolerance before the stage of diabetes and for monitoring patients treated with insulin.


Eligibility criteria:
inclusion criteria: * patients with cystic fibrosis aged over 18 * patients treated for 1 year by elexacaftortezacaftor-ivacaftor * normal tolerant or intolerant to glucose or presenting with cystic fibrosis related diabetes treated or not with insulin * patient who had a continuous glucose monitoring in the 6 months before and 6 months after one year of treatment with elexacaftor-tezacaftor-ivacaftor exclusion criteria: * patient not eligible for triple cftr modulator * patient intolerant to triple corrector * pregnant woman

Keywords: cystic fibrosis elexacaftor-tezacaftor-ivacaftor glucose tolerance abnormalities
pharmacological activation of hmn for osa

Conditions: Obstructive Sleep Apnea

Summary: obstructive sleep apnea (osa) is common and has major health implications but treatment options are limited. osa patients show a marked reduction in upper airway (ua) dilator muscle activity at sleep onset and this phenomenon leads to increased collapsibility of ua compared to normal subjects. in this protocol the investigators will test the effect of ltm1201l, ltm1201ln, ltm1201lb, ltm1201ld administered before sleep on osa phenotype traits and osa severity during sleep.


Eligibility criteria:
inclusion criteria: * ahi \> 10 events/h during nrem supine sleep exclusion criteria: * any medical condition other than well controlled hypertension and mild diabetes. * any medication known to influence breathing, sleep/arousal, or muscle physiology. * claustrophobia. * inability to sleep supine. * allergy to any of the medications tested in the protocol. * history of kidney stones, hypercalcemia, primary hyperparathyroidism, sarcoidosis, hypervitaminosis d. * individuals with underlying cardiac disease, such as arrhythmias. * individuals taking psychiatric medications, such as an mao-i, ssri or snri, or any of the studied medications for medical care. * for women: pregnancy. * pulmonary hypertension * severe osa with a mean sao2 lower than 88%
mini-trampoline intervention vs. nordic walking: balance, fitness and neuropsychological effects

Conditions: Overweight; Obesity

Summary: the effects of mini-trampoline training on balance, cardiorespiratory fitness, strength and neuropsychological parameters in an overweight or obese population are unknown. the aim of this 2-arm randomized controlled trial is to compare the effects of a 12-week mini-trampoline training and a 12-week nordic walking training on balance, fitness and strength in overweight/obese individuals.

a growing body of literature suggests, that obesity is not only associated with medical conditions such as diabetes, but also linked to altered gait, impaired balance and a greater likelihood of falls. weight reduction has been shown to improve balance controle. methods to increase physical activity are largely not accepted in this population and those which conserve the musculoskeletal system are rare. physical activity has been shown to influence mood, quality of life and eating behavior. mini-trampoline training has been shown to enhance stability and increase fitness.

Eligibility criteria:
inclusion criteria: * age 18-55 years * body mass index ≥25 kg/m2 * ≤ 1h regular exercise/ physical activity per week exclusion criteria: * cardiovascular or other chronic diseases not permitting sports participation * inability to follow the procedures of the study (e.g. due to dementia) * neurological disorders limiting balance or medications impairing balance * hypertensive blood pressure not permitting exercise (\>180/100 mmhg) * medication: beta-blocking agents which reduce cardiac adaption abilities to exercise * known pregnancy with contraindications for exercise according to the guidelines of the american college of obstetricians and gynecologists

Keywords: balance strength barriers towards exercise quality of life body dissatisfaction executive functions eating behavior fitness
impact of atkinson product design urinary slide valve versus standard catheter drainage system on social functioning

Conditions: Urinary Catheterization; Urinary Tract Infections

Summary: the primary objective of this study is to evaluate the impact of the atkinson product design urinary slide valve on patient morbidity and freedom as measured by impact on activities of daily living (adl) and quality of life (qol). secondary objectives include assessing the impact of the device on bacteruria and evaluating the impact of the primary treatment on adl and qol.

several indications exist in urologic practice where urinary drainage via a urethral catheter is required and an estimated 4 million patients in the united states undergo urinary catheterization per year.(1) though it is common for urine to be continually collected in a bag attached to the catheter by plastic tubing, catheter valves offer an alternative method of storing and voiding urine. catheter valves are small devices that fit into the external end of the urethral catheter. rather than continuous drainage, urine is stored in the bladder and emptied on regular intervals by opening the valve. this method of drainage may offer several benefits including preserving bladder capacity, function and tone, reducing catheter blockage in cases of urine bacterial colonization, and decreasing traction forces on the bladder neck by removing the downward weight of a collecting bag.(2-4) the use of a catheter valve may offer improvements in social functioning and mobility.(5) studies to date suggest that catheter valves are well tolerated by patients, but these studies have used non-standardized questionnaires and have not assessed overall quality of life.(5, 6) additionally, there may be an associated cost benefit to utilizing catheter valves compared to drainage bags.(5) further study in this area, focusing on quality of life and social functioning, will enable the clinician to better counsel patients on the risks and benefits of the various methods of urinary drainage.

Eligibility criteria:
inclusion criteria: 1. patients undergoing brachytherapy or cryotherapy for prostate cancer 2. patients undergoing thermal therapy for benign prostatic hyperplasia 3. patients undergoing catheterization to relieve urinary retention exclusion criteria: 1. patients with neurogenic bladder 2. patients with urinary tract infection 3. patients with gross hematuria 4. patients undergoing surgery with risk of urinary leak (ex: urethroplasty, radical prostatectomy, bladder repair) 5. female patients

Keywords: urinary catheterization urinary tract infections
comparison study of sentinel lymph node biopsy by multimodal method in breast cancer

Conditions: Breast Neoplasms

Summary: sentinel lymph node biopsy (slnb) has become a mainstay surgery method in breast cancer. it provides the surgeon the evidence of axillary lymph node metastasis, which determines the extent of surgery. because effective slnb can decrease the extent of axillary lymph node dissection, it is increasingly important. in general, radioactive colloid has been used for slnb. in order to pursue more precise slnb, the investigators developed a multimodal method enabling visual guidance with the mixture of indocyanine green, blue dye and radioisotope. in this study, our hypotheses are as following: 1. multimodal method enables to increase identification rate of slnb 2. blue dye and indocyanine green provide the surgeon visual guidance to ensure better outcome 3. multimodal method alleviates the shortcomings of indocyanine green and blue dye as an identification strategy

indocyanine green advantages: provides visualization of sentinel lymph node without incision blue dye advantages: easy to employ; no toxicity disadvantages: diffusion; absorption and disappearance of the marking within minutes radioisotope advantages: can be used for lesions not accessible to ultrasound; ideal for selective uptake to sentinel lymph node disadvantages: not able to use palpation and visualization, confirms by gamma-probe only

Eligibility criteria:
inclusion criteria: * clinically lymph node negative breast cancer patients * consented patients with more than 20 years exclusion criteria: * history of breast cancer * locally advanced breast cancer and metastatic breast cancer * proven axillary lymph node metastasis * history of axillary excisional or incisional biopsy, or dissection * history of neoadjuvant chemotherapy * pregnancy * non-consented patients * younger than 20 years old

Keywords: sentinel lymph node multimodal breast cancer